Events

ACCU-CHEK AVIVA METERS .. THIS PRODUCT DOES NOT HAVE REGISTRATION AT ANVISA. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Roche Diagnostics 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    821
  • 날짜
    2006-01-16
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • 데이터 추가 비고
    UNTIL THIS DATE DOES NOT INCLUDE REGISTRATION OF THE PRODUCT IN BRAZIL. ANVISA CONTACTS THE COMPANY ROCHE DIAGNÓSTICA BRASIL LTDA, WHICH HAS INFORMED THAT THE PRODUCT ACCU-CHEK AVIVA METERS IS SOLD ONLY IN THE FOLLOWING COUNTRIES: UNITED STATES, CANADA, DENMARK, NORWAY, SWEDEN, BELGIUM, LUXEMBOURG, HOLLAND, GERMANY, SWITZERLAND, UNITED KINGDOM , SPAIN, PORTUGAL, ITALY AND GREECE.
  • 원인
    According to the fda website (http://www.Fda.Gov/opacom/enforce.Html), roche diagnostics has issued a voluntary worldwide recall of certain product series accu-chek aviva meters , due to a potential risk of electronic malfunction of the product, which may cause errors in results or an interruption and may no longer be possible to use. the numbers of affected series marketed in the united states include: from 52500000000 to 52510999999. the recall does not apply to meters with n. of series 52511000000 or greater, as well as accu-chek aviva test strips meters. this information is available on the accu-chek website http://www.Accu-chek.Com/us/rewrite/generalcontent/en_us/article/accm_general_article_3072.Htm outside the united states, the collection includes no. from series 52600000000 to 52610999999, 52700000000 to 52710999999; and 52800000000 to 52810999999.
  • 조치
    According to the information on the FDA website, ROCHE DIAGNOSTICS has contacted customers who have received units from the affected product series in different countries and is already making the due payment.

Device

ACCU-CHEK AVIVA METERS .. THIS PRODUCT DOES NOT HAVE REGISTRATION AT ANVISA.

Manufacturer

Roche Diagnostics
  • Source
    ANVSANVISA